Risk Register

A really good way to ensure consistency throughout the risk file is to use a risk register.

This can be as simple as a list of all harms and the related severity.

This can be far more complex as well, linking hazardous situations to harms and severities.

Back in an earlier module we mentioned that the FDA maintains a list of harms.

If you can ensure alignment with something like that, both understandability (by regulatory authorities and clinical experts) is well-served.

You’ll also find that your risk controls end up being a finite list, applying the same control on multiple risks.

A risk register can help ensure controls are consistent when they are ‘reused.’

It’s easy to have risk controls that are intended to be the same but are worded differently.

This is especially easy when the same control is applied in different areas (e.g., Software FMEA and Usability FMEA).

The same control stated differently WILL cause headaches.  Find a way to ensure that controls are consistent as well.

One approach is to have a set of reference cells in a spreadsheet and use those to select from when populating the FMEA then auto-populate other fields (e.g., severity) as appropriate.